A standardised assessment method for risk exposure and protective measures

Hospital staff are required to handle potentially toxic medicines every day. Protecting the healthcare of the workforce is a legal requirement, making it absolutely essential to clearly identify the high-risk drugs which are in use in the hospital, in order to put in place appropriate protective measures.
The risks and associated protective measures relating to the handling of parenteral cytotoxic medicines are well known, but there is a shortage of data relating to other products such as antivirals or monoclonal antibodies. As a result the handling practices for these products can vary greatly between institutions. In response to this situation we have developed a standardised assessment method for risks linked to the handling of potentially toxic products, including some recommended protective measures.
The chronic toxicity (mutagenicity, carcinogenicity) of each active ingredient was first calculated on the basis of information given in the Material Safety Data Sheets (MSDS) and data issued by the International Agency for Research on Cancer (IARC). For each product we used the MSDS data to evaluate the properties liable to irritate or sensitize the skin, eyes or respiratory system, in order to define the acute toxicity risk.

Teratogen risks or properties toxic to the reproductive system were identified using the MSDS and the pregnancy categories outlined by the Food and Drugs Administration (FDA). These risks were considered separately in order to ultimately produce specific protective recommendations for women who are pregnant or seeking to conceive. These three forms of toxicity were then weighted according to the real exposure risk linked to the galenic form or delivery method of the specific pharmaceutical product. The risk of contact with the skin, eyes or lungs inherent to each form or delivery method was determined by consensus during consultations with a group of professionals, pharmacists and clinical pharmacologists.

Protective measures (centralisation of product reconstitution within the Pharmacy department, wearing of gloves, masks or safety glasses) were defined in relation to the acute and chronic toxicities of the active ingredients and the exposure risk linked to handling them. Due to the practice of weighting these risks according to the form and delivery method for the drugs, the measures we have proposed offer sufficient protection while remaining practical and easily applicable.
We analysed and produced targeted protective recommendations for over 50 active ingredients, including monoclonal antibodies, antivirals, immunosuppressants and hormonal agents in many galenic forms and delivery methods.
In practice, 25% of pills and capsules should be crushed centrally in the Pharmacy department. 38% of the lyophilisates and 17% of the intravenous solutions analysed should also be reconstituted centrally in Pharmacy.

To conclude, the development of a standardised method for assessing the toxicity of therapeutic drugs with reference to their form and delivery method has allowed us to identify potentially dangerous products and produce recommendations which are uniform and applicable to all hospital staff. Moreover, this algorithm has allowed us to rationalise protective measures and establish a list of toxic substances which is more objective and sometimes more restricted than similar lists in the existing literature.

Diapos - Méthode standardisée d’évaluation du risque d’exposition